Key Duties and Responsibilities • Manage clinical studies by planning and assisting in study start-up activities such as the creation of Monitoring Plan, Laboratory Manual, Pharmacy Manual, Site Initiation Presentations, CRF Completion Guidelines and various forms and study tracking and management documents. • Assist with oversight and management of CRO, including project tracking of subject and site information. • Assist with the development of site tools and clinical trial start up activities. • Establish and maintain the documents within electronic and/or paper Trial Master File with minimal supervision. • Receive and review all regulatory documents from sites for accuracy and compliance to company SOPs and federal guidelines, tracks all information for reference, and maintains documentation as required. • Review site study documents (e.g., informed consent template and study tools/worksheets). • Assist and/or contribute to the creation and maintenance of study materials for clinical studies, including but not limited to site and CRA training material, regulatory document templates, study binders, study plans, study communications and presentations. • Assist clinical operation leads in the development, handling, distribution, filing and archiving of essential documents in the TMF. • Handle incoming and outgoing clinical trial related materials shipments to site, study team, CRAs and vendors, as needed. • Provide assistance in confirming and verifying vendor or site contracts, as well as reviewing associated invoice expenditures for accuracy and compliance. • Assist with all aspects of initial study drug/device shipment release including regulatory packet review and study-drug release. • Assist clinical study team with the planning, preparation, and on-site support of investigators’ meetings. • Perform or oversee CRO pre-site selection and site initiation, as well as interim, close-out, and co-monitoring visits to ensure compliance with protocol and regulatory requirements, to assure good site performance, and evaluate CRO CRA performance. • Communicate directly with sites, Contract Research Organizations (CROs) and CRAs to obtain updated information, essential documents, etc. to assist with driving start-up, study conduct, and/or close out activities. • Review and manage monitoring report review and follow-up within project-specific timelines. • Assist with tracking of clinical trial progress including status update reports, as requested. • Comply with company regulatory, safety and compliance procedures and practices.